A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

Last updated: December 7, 2020
Sponsor: Bucci Laser Vision Institute
Overall Status: Completed

Phase

4

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

N/A

Clinical Study ID

NCT01296542
2011-BV-C
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Man or woman 18 years of age or older.
  • Physically capable of instilling eye drop or have an appropriate person available toassist in administration of eye drops 4 times a day.
  • Scheduled for phacoemulsification with intraocular lens (IOL) implantation for thetreatment of cataract.
  • Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and bemedically cleared for surgery.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.
  • Subjects must have signed an informed consent document indicating that they understandthe purpose of and procedures required for the study and are willing to participate inthe study.

Exclusion

Exclusion Criteria:

  • Known allergy or contraindication to the test article(s) or their components.
  • Presence of any abnormality or significant illness in the eye that in theinvestigator's opinion could affect the subject's health or the study parameters.
  • Presence of an active ocular infection (bacterial, viral or fungal), or positivehistory of ocular herpetic infection.
  • History of any significant illness that could be expected to interfere with the studyparameters. Any condition that, in the opinion of the investigator, would compromisethe well-being of the subject or the study.
  • Use of disallowed therapies (systemic or topical):
  • Fluoroquinolone anti-infective agents (systemic or topical) within 1 week ofVisit 1 or anytime after Visit 1 for the duration of the study.
  • Use of contact lenses for one week prior to the study and for the duration of thestudy.
  • Received an experimental drug or used an experimental medical device within 21 daysbefore the planned start of treatment.

Study Design

Total Participants: 60
Study Start date:
May 01, 2011
Estimated Completion Date:
January 31, 2013

Connect with a study center

  • Bucci Laser Vision Institute

    Wilkes-Barre, Pennsylvania 18702
    United States

    Site Not Available

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